#06-5558 Accrd Manual V7 - COLA

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CRITERIA FOR QUALITY LABORATORY PERFORMANCE>PST 20 RIs a record kept of who was notified when a test result has exceeded the alert (panic) value established by thelaboratory?A record, either paper or electronic, must be kept indicating when an appropriate individual is notified of aalert (panic) value. At a minimum the record should include who was notified, when and by whom. As previouslynoted miscommunication can be a significant source of errors in the health care environment. For thisreason laboratories should utilize a read back requirement whenever providing patient results verbally. It isadvisable to define this in the procedure for notification as well as including a reminder of the requirementon logs or documents used for notification.PST 21 RAre the personnel who performed the test identified on the testing record and test report?Each test record and test report should have a space for the person performing the test to initial it.PST 22 RAre test records, including instrument printouts that contain patient results, maintained for at least two years?All instrument printouts and/or tapes must be retained for two years unless they are directly interfaced withthe laboratory information system. Remember that heat sensitive paper printouts tent to fade over time, soyou may need to make photocopies of them in order to preserve them for two years.PST 23 RAre original or exact duplicate results maintained in a manner that makes them accessible for prompt retrieval?PST 24 RAre all original or exact duplicate test reports (from in-house tests and reference laboratories) maintained,stored and preserved for at least two years?The laboratory must have a system for retaining copies of all reports including original, preliminary, correctedand final reports.PST 25 RAre all immunohematology original or exact duplicate test reports and test records (from in-house or referencelaboratories) maintained, stored and preserved for at least five years?PST 26 RAre all pathology and Pap smear reports (from in house tests and reference laboratories) maintained, storedand preserved for at least 10 years?This requirement only pertains to laboratories that process Pap and pathology requests and reports throughthe laboratory. Be aware that state regulations may mandate longer retention.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT <strong>COLA</strong> PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org53
CRITERIA FOR QUALITY LABORATORY PERFORMANCEPST 27 RMINIMUM RECORD RETENTION REQUIREMENTSIt is a legal requirement that all laboratories ceasing operation make provisions to ensure that all records,slides, blocks and tissue are maintained and preserved, and available for the time frames specified in thissection.Laboratory Document & Record Retention RequirementsDocument or Record MinimumTime frame CommentsRequisitions 2 years Patient chart or medical records is acceptable form ofrequisition provided all required components are presentTest proceduresQC Records2 years beyond dateof discontinuance2 yearsPatient test records 2 years Includes instrument printouts.Patient chart or medicalrecord is acceptable form of report provided all requiredcomponents are present.Maintenance &Calibration records2 yearsPerformance Specification As long as test system Not less than 2 yrsVerification recordsin useBlood and Blood product See FDA Appendix Exceptions or modifications shall be made only uponrecordswritten approval issued by the Director, Center forBiologics Evaluation & Research (CBER)Immunohematology testrecords & reports5 yrsTransfusion Records 5 years after records of Records must be maintained concurrently with theprocessing have been performance of each significant step in the collection,completed OR 6 months processing, compatibility testing, storage, andafter the latest expiration distribution of each unit of blood and blood componentsdate for the individual so that all steps can be clearly traced.product – which ever isthe later date.All records must be legible and indelible. They mustinclude the following:If there is no expiration • identification of the person performing the workdate, the records must be • dates for all entriesmaintained indefinitely. • test results as well as interpretation of results• expiration dates assigned to specific productsProficiency Testing Records2 years54. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT <strong>COLA</strong> PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org
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#06-5558 Accrd Manual V7 - COLA

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